Candice D. Fike, Judy L. Aschner, Charul Avachat, Angela K. Birnbaum, Catherine M. T. Sherwin
University of Utah Health. Albert Einstein College of Medicine. Hackensack Meridian School of Medicine. University of Minnesota. Wright State University Boonshoft School of Medicine.
United States
Journal of Perinatology
J Perinatol 2023;
DOI: 10.1038/s41372-023-01809-y
Abstract
Objective: Information is needed to guide the design of randomized controlled trials (RCTs) evaluating L-citrulline therapy for premature infants with pulmonary hypertension associated with bronchopulmonary dysplasia (BPD-PH). Based on our single-dose pharmacokinetic study, we evaluated the ability of a multi-dose enteral L-citrulline strategy to achieve a target trough steady-state L-citrulline plasma concentration and its tolerability in premature infants.
Study design: Plasma L-citrulline concentrations were measured in six premature infants receiving 60 mg/kg L-citrulline every 6 h for 72 h before the first and last L-citrulline doses. L-citrulline concentrations were compared to concentration-time profiles from our previous study.
Results: Target trough plasma L-citrulline concentrations were achieved in 2/6 subjects. No serious adverse events occurred.
Conclusions: Multi-dose L-citrulline was well tolerated. These results will assist in the design of phase II RCTs evaluating L-citrulline dosage strategies to achieve target plasma L-citrulline concentrations in infants at risk for BPD-PH.
Category
Class III. Pulmonary Hypertension Associated with Lung Disease
Medical Therapy. Pharmacokinetics and Pharmacology
Age Focus: Pediatric Pulmonary Vascular Disease
Fresh or Filed Publication: Filed (PHiled). Greater than 1-2 years since publication
Article Access
Free PDF File or Full Text Article Available Through PubMed or DOI: Yes